letter from the FDA


responding to a request to take RU-486 (mifeprex) off the market.

Thank you for your message to the Division of Drug Information in the Center for Drug Evaluation and Research (CDER).

As you know, the Food and Drug Administration has been informed of two
additional deaths following medical abortion with mifepristone (Mifeprex). The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment.
In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.

As previously provided in our July 19, 2005 Public Health Advisory, updated on November 4, 2005, the Agency is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone (Mifeprex) and misoprostol. All four cases of fatal infection tested positive for Clostridium sordellii. All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol. In
addition, FDA tested drug from manufacturing lots of mifepristone and misoprostol and found no contamination with Clostridium sordellii.

We do not know whether these new deaths were caused by sepsis or, if they were, if they were caused by infection with Clostridium sordellii.

You may read more about this topic at the following site

CDER/Division of Drug Information bmd
Disclaimer: This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

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This page contains a single entry by alicia published on March 24, 2006 9:54 PM.

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